Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: A Pilot, Placebo-controlled, Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Feasibility (pertaining to patient recruitment)
研究概览
简要总结
A common long-term side effect of anti-rejection (immunosuppressant) medications is skin cancer. This pilot clinical trial evaluates the feasibility of conducting a larger pivotal trial to examine the efficacy and safety of nicotinamide for prevention of keratinocyte carcinoma in solid organ transplant recipients. This pilot trial will transition into the pivotal trial if all feasibility targets are met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Kidney, liver, heart, or lung transplant at least two years ago
- •History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ
- •Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus)
- •Able to attend follow-up visits
- •Able to speak and understand English (only for cognitive substudy)
排除标准
- •Use of mTOR inhibitor (sirolimus, everolimus) within the past 12 weeks
- •Biopsy-confirmed acute rejection episode within the past 12 weeks
- •Active liver disease (elevated AST or ALT >3 times normal)
- •Severe renal failure (estimated glomerular filtration rate <20 mL/min/1.73 m2)
- •Current carbamazepine or primidone use
- •Pregnancy and lactation
- •Gorlin syndrome or other genetic skin cancer syndrome
- •Solid organ or hematologic malignancy, invasive Stage II melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years, or invasive Stage I melanoma within the past two years
- •Untreated localized skin cancer (invasive squamous cell carcinoma, basal cell carcinoma, or keratoacanthoma) at baseline (the patient can enrol after skin cancer treatment)
- •Use of nicotinamide or niacin (250 mg or more daily) within the past 12 weeks
- •Use of field therapy for actinic keratoses within the past 12 weeks
- •Initiation of systemic chemoprevention within the past 12 weeks
研究组 & 干预措施
Nicotinamide
干预措施: Nicotinamide (Drug)
Placebo
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Feasibility (pertaining to patient recruitment)
时间窗: 1 year
Proportion of patients who consent to data linkage to provincial administrative databases
Feasibility (pertaining to appropriateness of eligibility criteria)
时间窗: 1 year
Reasons for exclusion of screened patients
Feasibility (pertaining to adherence to intervention)
时间窗: 1 year
Proportion of capsules returned, reasons for non-adherence
Feasibility (pertaining to adherence to follow-up assessments)
时间窗: 1 year
Proportion of missed assessments and incomplete questionnaire data variables, proportion of patients who withdraw from the trial, patient perception of trial participation
Feasibility (pertaining to data linkage)
时间窗: 1 year
Proportion of patients who consent to data linkage to provincial administrative databases
Drug interactions
时间窗: 2 weeks
Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 2 weeks. This measurement will be dropped if all cases of clinically relevant drug interactions manifest at 1 week in the first 20 enrolled participants.
Preliminary pooled keratinocyte carcinoma event rate
时间窗: 1 year
Pooled keratinocyte carcinoma event rate to be used for sample size re-estimation in the pivotal trial.
Serious adverse events
时间窗: 1 year
Descriptive tabulation (preliminary safety)
次要结局
- Pooled standard deviation of Animal Naming Task scores (substudy)(1 year)
- Pooled standard deviation of cognitive test scores (substudy)(1 year)
- Pooled standard deviation of serum phosphate levels (substudy)(1 year)
- Pooled standard deviation of Trail Making A and B test scores (substudy)(1 year)
- Pooled standard deviation of Controlled Oral Word Association test scores (substudy)(1 year)
- Feasibility of recruiting for neurocognitive substudy(1 year)
- Pooled standard deviation of MoCA test scores (substudy)(1 year)
- Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy)(1 year)
- Baseline prevalence of cognitive impairment (substudy)(1 year)